FDAsafety guidance72% confidence
Early Alert: Intravascular Administration Set Issue from Baxter
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Baxter.
Regulatory Analysis
Baxter administration sets may have air bubbles in the drip chamber and tubing, which may result in air being delivered through the IV line to the patient.
Supporting Context
- Therapeutic area
- Medical Devices · IV Administration
- Sub-indication
- General
Related signal: Baxter Faces Early Alert Over Intravascular Administration Set Air Bubble Issue